ATG Plus PTCy vs ATG for CGVHD Prophylaxis

NCT ID: NCT04202835

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2026-02-07

Brief Summary

A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.

Detailed Description

Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.

Conditions

Acute Leukemia; Myelodysplasia; Chronic Graft-versus-host-disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ATG/PTCy

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Post Transplant Cyclophosphamide

Anti-Thymocyte globulin (rabbit)

Intervention Type: DRUG

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

ATG

Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).

Group Type: ACTIVE_COMPARATOR

Anti-Thymocyte globulin (rabbit)

Intervention Type: DRUG

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Interventions

Cyclophosphamide

Post Transplant Cyclophosphamide

Intervention Type: DRUG

Anti-Thymocyte globulin (rabbit)

Anti-Thymocyte Globulin (rabbit, Thymoglobulin)

Intervention Type: DRUG

Other Intervention Names

Thymoglobulin

Eligibility Criteria

Inclusion Criteria

1. The participant is aged ≥ 16 and deemed medically fit per investigator for protocol

2. The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome

3. The participant will receive a blood progenitor cell graft ("HPC, Apheresis")

4. The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.

5. The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.

6. The participant has good performance status (Karnofsky ≥60%)

7. The participant is able to understand and sign the informed consent form

8. Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.

9. The participant is receiving their first transplant

Exclusion Criteria

1. The participant is HIV antibody positive

2. The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.

3. The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)

4. The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment

5. The participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3

6. The participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3

7. The participant has urinary outflow obstruction

8. The participant is in poor condition (determined per institutional guidelines)

9. The participant has acute leukemia in relapse

10. The participant has myelodysplastic syndrome with > 10% marrow blasts

11. The participant is having their second transplant

12. The participant is taking T-cell antibody prophylaxis (anti-CD52)

13. The participant is receiving a cord blood graft or T-cell depleted grafts

14. The participant has mixed phenotype acute leukemia

15. The participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the sponsors.

16. The participant is in complete remission with incomplete recovery (CRi)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cell Therapy Transplant Canada

UNKNOWN

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Ozmosis Research Inc.

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irwin R Walker, MBBS

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Kristjan Paulson, MD

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Locations

Kinghorn Cancer Centre, St Vincent's Health Network

Darlinghurst, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Australasian Leukaemia and Lymphoma Group

Melbourne, Victoria, Australia

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Saskatchewan Cancer Agency

Saskatoon, Saskatchewan, Canada

Countries

Australia; Canada

Other Identifiers

OZM-099

Identifier Type: OTHER

Identifier Source: secondary_id

CTTC1901

Identifier Type: -

Identifier Source: org_study_id